Trexall (methotrexate) is an antimetabolite drug that is used to treat some cancers, severe skin diseases such as severe psoriasis, and to treat forms of rheumatoid arthritis. Trexall is available in generic form as methotrexate. Side effects of Trexall include:

Severe side effects occur more frequently in patients taking the high doses of Trexall.

Trexall is supplied in 5, 7.5, 10, and 15 mg tablets. The dose is designed for each patient's problem and can range from about 7.5 mg per week to 30 mg per day, depending on the disease process and the doctor's judgment. Trexall has been used in children with juvenile rheumatoid arthritis, but most doses were individualized. Trexall may interact with azathioprine, chloramphenicol, hydroxychloroquine, retinol, tretinoin, isotretinoin, steroids, sulfa drugs, phenytoin, probenecid, tetracycline, theophylline, gold treatments, oral diabetes medications, penicillin antibiotics, medicines that reduce stomach acid, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates such as aspirin and others. Tell your doctor all medications and supplements you use. This drug should not be used in pregnant or breastfeeding women due to likely harm to the fetus or infant.

Our Trexall Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS

IN GENERAL, THE INCIDENCE AND SEVERITY OF ACUTE SIDE
EFFECTS ARE RELATED TO DOSE AND FREQUENCY OF ADMINISTRATION. THE MOST SERIOUS REACTIONS
ARE DISCUSSED ABOVE UNDER ORGAN SYSTEM TOXICITY IN THE PRECAUTION SECTION. THAT
SECTION SHOULD ALSO BE CONSULTED WHEN LOOKING FOR INFORMATION ABOUT ADVERSE
REACTIONS WITH METHOTREXATE.

Other adverse reactions that have been reported with
methotrexate are listed below by organ system. In the oncology setting,
concomitant treatment and the underlying disease make specific attribution of a
reaction to methotrexate difficult.

Adverse Reactions In Double-Blind Rheumatoid Arthritis
Studies

The approximate incidences of methotrexate attributed (i.e.,
placebo rate subtracted) adverse reactions in 12 to 18 week double-blind
studies of patients (n=128) with rheumatoid arthritis treated with lowdose oral
(7.5 to 15 mg/week) pulse methotrexate, are listed below. Virtually all of
these patients were on concomitant nonsteroidal anti-inflammatory drugs and
some were also taking low dosages of corticosteroids. Hepatic histology was not
examined in these short-term studies. (See PRECAUTIONS.)

Adverse Reactions In Psoriasis

There are no recent placebo-controlled trials in patients
with psoriasis. There are two literature reports (Roenigk, 1969 and Nyfors,
1978) describing large series (n=204, 248) of psoriasis patients treated with
methotrexate. Dosages ranged up to 25 mg per week and treatment was
administered for up to four years. With the exception of alopecia,
photosensitivity, and “burning of skin lesions” (each 3% to 10%), the adverse
reaction rates in these reports were very similar to those in the rheumatoid
arthritis studies. Rarely, painful plaque erosions may appear.

Adverse Reactions In JRA Studies

The approximate incidences of adverse reactions reported
in pediatric patients with JRA treated with oral, weekly doses of methotrexate
(5 to 20 mg/m²/wk or 0.1 to 0.65 mg/kg/wk) were as follows (virtually all
patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and
some also were taking low doses of corticosteroids): elevated liver function
tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea),
11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness,
0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m²/wk
in JRA, the published data for doses above 20 mg/m²/wk are too limited to
provide reliable estimates of adverse reaction rates.